Westlake Personalized Nutrition and Health Cohort for Drug Addicts

NCT04105621 | Completed DMC

• 1 other identifier: 20190812ZJS0009
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study of drug addicts confined in Zhejiang rehabilitation centers. The primary aim of this study is to investigate the association between diet and health status among drug addicts. The second aim is to characterize the continuous blood glucose response to dietary intakes over 2 weeks. The third aim is to describe the dynamic changes of gut microbiota at three time points in drug addicts during compulsory detoxification and to evaluate the association between gut microbiota, diet and addiction severity.

Conditions

Drug Addiction; Undernutrition; Drug Abuse

Keywords

Personalized nutrition; Drug addicts; Gut microbiota

Outcome Measures

Primary Outcomes (2)

• Continuous blood glucose profile over 2 weeks

  Glucose levels were measured using continuous glucose monitoring over 2 week

  Two weeks after enrollment

• The dynamic change of gut microbiota within one year

  Fecal microbiota was analyzed using16S rRNA gene sequencing technique

  One year after enrollment; includes three sampling time points: baseline, 6 months after enrollment and 12 months after enrollment.

Secondary Outcomes (6)

• Drug craving intensity

  Baseline; 6 months after enrollment; 12 months after enrollment

• The change of BMI

  Baseline; 6 months after enrollment; 12 months after enrollment

• Nutritional status

  Baseline; 6 months after enrollment; 12 months after enrollment

• The degree of depression

  Baseline; 6 months after enrollment; 12 months after enrollment

• The degree of anxiety

  Baseline; 6 months after enrollment; 12 months after enrollment

Study Arms (2)

Drug addicts

This group included drug addicts lived in drug rehablitation center.

Healthy population

We recruited the healthy participants from the Westlake N-of-1 Trials for Macronutrient Intake (NCT04125602) as healthy control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Drug addicts confined in Zhejiang drug rehabilitation centers will be recruited.

You may qualify if:

• Drug addicts aged between 18 yrs and 65yrs.
• Drug addicts lived in Zhejiang drug rehabilitation centers.
• Drug addicts who have stayed in drug rehabilitation center for no more than 6 months.

You may not qualify if:

• Drug addicts diagnosed with cancer or other serious physical and mental disorders.

Sponsors & Collaborators

• Westlake University: lead
• Zhejiang Drug Rehabilitation Administration: collaborator

Study Sites (1)

Zhejiang Drug Rehabilitation Administration

Hangzhou, Zhejiang, 310008, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fasting venous blood, urine, saliva and stool.

MeSH Terms

Conditions

Substance-Related Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ju-Sheng Zheng, PhD

  Westlake University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 26, 2019
• Study Start: October 28, 2019
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: April 14, 2021

Record last verified: 2020-10

Locations

CN (1)